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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALTAPORE; FILLER, BONE VOID, CALCIUM COMPOUND

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BAXTER HEALTHCARE CORPORATION ALTAPORE; FILLER, BONE VOID, CALCIUM COMPOUND Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported from an anonymous survey result that the fusion rate observed at the 12 month follow up after use of altapore for implantation in place of cortico-cancellous or cancellous allograft or autograft bone in low load or compression environments for plastic/reconstructive surgery procedures was 51-60%.The physician reported "tibia fractures, facial fractures sometimes have ended up requiring supplemental autologous bone grafting after failure to achieve union with traditional approach.Usually in setting of osteomyelitis¿.At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
 
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Brand Name
ALTAPORE
Type of Device
FILLER, BONE VOID, CALCIUM COMPOUND
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - ELSTREE
370 centennial avenue
elstree, borehamwood
hertfordshire WD6 3 TJ
UK   WD6 3TJ
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10714381
MDR Text Key212385037
Report Number1416980-2020-06545
Device Sequence Number1
Product Code MQV
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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